Prospect: information for the user

Lacidipino Teva 4 mg film-coated tablets EFG

Lacidipino

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist or nurse.
• This medicine has been prescribed only for you, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are not listed in this prospect. See section 4.

1.What is Lacidipino Teva and for what it is used

2.What you need to know before starting to take Lacidipino Teva

3.How to take Lacidipino Teva

4.Possible adverse effects

5.Storage of Lacidipino Teva

6.Contents of the package and additional information

Lacidipino Teva contains a medicine called lacidipino. This belongs to a group of medicines called “calcium channel blockers”. Lacidipino Teva helps to relax blood vessels so they are more dilated. This helps blood to flow more easily and reduces blood pressure. Lacidipino Teva taken regularly as prescribed by your doctor helps to lower your blood pressure (to treat hypertension).

Do not take Lacidipino Teva

• If you are allergic to lacidipine, other calcium channel blockers, or any of the other components of this medication (listed in section 6).
• If you have a severe heart problem called “aortic stenosis”. This is a narrowing of one of the valves in your heart, which reduces blood flow.

Do not take Lacidipino Teva if you have any of the above circumstances. If you are unsure, consult your doctor or pharmacist before taking Lacidipino Teva.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before taking Lacidipino if:

• You have an irregular heartbeat or any other heart problem.
• You have or have had any liver problems.
• You have had a heart attack in the last month or if you have chest pain (angina).

Children and adolescents

Lacidipino Teva is not recommended for use in children and adolescents under 18 years old.

Taking Lacidipino Teva with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication. This includes herbal medications. This is because this medication may affect how other medications work. Other medications may also affect how Lacidipino Teva works.

Particularly, inform your doctor or pharmacist if you are taking any of the following medications:

• Medications to increase blood pressure.
• Medications to treat fungal infections.
• Medications to control heart rhythm (called “antiarrhythmics”).
• Medications for depression called “tricyclic antidepressants”.
• Medications for allergies (e.g., terfenadine).
• Antibiotics (e.g. rifampicin, erythromycin).
• Some antipsychotics (medications to treat schizophrenia and other psychotic disorders).
• Cimetidine – used for gastrointestinal disorders.
• Ciclosporin (immunosuppressant agent used, e.g. for transplant recipients).
• Corticosteroids or tetracosactide for the treatment of inflammatory bowel disease (IBD), Crohn's disease, arthritis, and osteoarthritis.

If you are to undergo a blood test, inform that you are taking this medication. This is because Lacidipino Teva may affect liver-related test results.

Taking Lacidipino Teva with food, drinks, and alcohol

You can take this medication with an empty stomach or with food.

Do not take this medication with grapefruit juice. Do not consume alcohol during treatment with this medication.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machinery

You may feel dizzy while taking Lacidipino Teva. If this happens, do not drive or operate tools or machinery.

Lacidipino Teva contains lactose and sodium

If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medication.

This medication contains less than 1 mmol of sodium (23 mg) per tablet: this is, essentially “sodium-free”.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

It is essential to take the correct number of tablets at the same time.

Adults

• The recommended dose is 2 mg per day, preferably in the morning with or without food.
• After 3-4 weeks, it may be increased to 4 mg each morning.
• If necessary, it may be increased again to 6 mg each morning, which is the maximum daily dose.

Administration Form

• Swallow the tablets whole with water.
• Take the tablets every day at the same time, preferably in the morning.
• Do not take them with grapefruit juice.
• The tablet can be divided into equal doses.

If you take more Lacidipino Teva than you should

If you take more of this medication than you should, consult your doctor, go directly to the hospital, or call the Toxicological Information Service, phone 91 562 04 20. Please bring this leaflet, any tablets, and the packaging to the hospital or doctor so they know which tablets you have taken. You may need medical treatment.

A overdose may cause effects such as irregular heartbeat, rapid and irregular breathing, low blood pressure, cold and clammy skin, dizziness or fainting, weakness or illness.

If you forget to take Lacidipino Teva

If you forget to take a tablet, take it as soon as you remember on the same day. However, if it is almost time for the next tablet, you should skip the missed dose and take the next one as usual. Do not take a double dose to compensate for the missed doses.

If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

Inform your doctor immediately if you notice the following adverse effects:

• Chest pain (angina), including chest pain that worsens (rare: may affect up to 1 in 100 people).
• Angioedema (allergic reaction causing facial swelling) (rare: may affect up to 1 in 1,000 people).

The following adverse effects have been reported:

Frequent (may affect up to 1 in 10 people):

• Headache.
• Dizziness.
• Redness.
• Fast or irregular heartbeat (tachycardia or palpitations).
• Stomach discomfort (nausea).
• Itching.
• Increased urine output (polyuria).
• Weakness (asthenia).
• Swelling (edema), particularly in the ankles.
• Changes in blood test results related to the liver.

Rare (may affect up to 1 in 100 people):

• Low blood pressure (hypotension).
• Fainting.
• Gingival hyperplasia (inflammation of the gums).

Rare (may affect up to 1 in 1,000 people):

• Urticaria.
• Muscle cramps.

Very rare (may affect up to 1 in 10,000 people):

• Tremor.
• Depression.

Unknown (cannot be estimated from available data):

• Tremors or tics, changes in muscle tone, and slowness of movement.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the blister and on the packaging after CAD or EXP. The expiration date is the last day of the month indicated.

Keep the blister in the case to protect it from light.

Medications should not be thrown down the drains or in the trash.Dispose of the packaging and medications you no longer need at the SIGRE point of the pharmacy.If in doubt, please ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Lacidipine Teva Composition

The active ingredient is lacidipine.

Lacidipine Teva 4 mg film-coated tablets: Each tablet contains 4 mg of lacidipine.

The other components are:

Core: povidone K-30, anhydrous lactose, sodium carboxymethylcellulose type A (from potato), magnesium stearate.

Coating: titanium dioxide (E-171), hydroxypropylmethylcellulose (E-464), gum arabic (E-414), lactose monohydrate, talc (E553b).

Product appearance and packaging contents

Lacidipine Teva 4 mg film-coated tablets: White, oval, biconvex tablets, engraved with “4”, scored and “LC” on one face and flat on the other.

The tablets are packaged in aluminum blisters.

Lacidipine Teva tablets are available in blisters of 14, 15, 28, 30, 56, 60, 84, 90, 98, and 100 tablets.

Not all packaging sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Teva Pharma, S.L.U.

Anabel Segura 11, Edificio Albatros B, 1st floor.

28108 Alcobendas. Madrid.

Manufacturer:

TEVA Pharmaceutical Works CO. LTD

Pallagi út 13, 4042 Debrecen

Hungary

or

Pharmachemie B.V.

Swensweg 5, 2031 GA Haarlem

Netherlands

or

Teva Operations Poland Sp.z.o.o

ul. Mogilska 80, 31-546 Krakow

Poland

or

Teva Czech Industries s.r.o.

Ostravska 29, c.p. 305, 747 70 Opava-Komarov

Czech Republic

This medicinal product is registered in the Member States of the EEA with the following names:

Denmark:Lacidipin Teva

Slovenia: Lacidipin Teva 4 mg filmsko obložene tablete

Spain:Lacidipino Teva 4 mg comprimidos EFG

Italy:Lacidipina Teva 4 mg compresse rivestite con film

Netherlands:Lacidipine 4 mg Teva, filmomhulde tabletten

Last review date of this leaflet:December 2022

Detailed information about this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http: //www.aemps.gob.es/

You can access detailed and updated information about this medicinal product by scanning the QR code included in the carton with your smartphone. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/73875/P_73875.html

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